vulva carcinoma
Conditions
Interventions
): a maximum of 6 courses of Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3
weekly schedule
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Woman >= 18 years • Signed and written informed consent. • Histologically confirmed squamous cell vulvar carcinoma • World Health Organization performance status of 0-2 • Adequate hematological function • Adequate hepatic function • Adequate renal function • Negative pregnancy test for woman of childbearing potential • Histologically or CT scan confirmed metastatic squamous cell vulvar carcinoma • Measurable disease • TNM stage any T any N M1
Exclusion criteria
Exclusion criteria: • Vulvar cancer other than squamous cell carcinoma at biopsy • Patients with metastasis limited to the pelvic lymph nodes, who can be primarily operated with curative intent • Other diagnosis of malignancy or evidence of other malignancy for 5 years before screening for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate and tumour size reduction by neo adjuvant chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives are chemotherapy related morbidity will be monitored as well as be disease free and overall survival and patterns of recurrence. | — |
Countries
Netherlands
Outcome results
None listed